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Site Quality Head Jobs (Hybrid work)

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Site Quality Head
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Lead the Quality team at our Cartago, Costa Rica plant, ensuring regulatory compliance and product excellence for medical devices. This senior role requires a BS in Science/Engineering, 10+ years in Pharma/Med Device quality, and strong management experience. You will drive GMP compliance, develo...
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Costa Rica , Cartago
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Not provided
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Explore Site Quality Head jobs and discover a pivotal senior leadership role at the heart of manufacturing excellence, particularly within highly regulated industries like pharmaceuticals, medical devices, and biotechnology. A Site Quality Head is the ultimate guardian of product quality, safety, and regulatory compliance for an entire manufacturing facility. This executive position carries the profound responsibility of ensuring that every product leaving the site meets stringent global standards, thereby protecting patient health and upholding the company's reputation. Professionals in these jobs typically oversee the site's complete Quality Management System (QMS). Their core mission is to establish, maintain, and continuously improve all quality system processes. This includes ensuring strict adherence to Good Manufacturing Practices (GMP), ISO standards, FDA regulations, and other applicable regional and international guidelines. They serve as the official Management Representative for regulatory bodies, acting as the primary point of contact during audits and inspections. A critical aspect of the role involves setting strategic quality objectives, tracking key performance indicators (KPIs), and reporting on the quality system's effectiveness to site and corporate leadership. Common responsibilities for a Site Quality Head encompass a broad spectrum of quality assurance and control activities. They are accountable for the quality of all incoming materials, in-process production, and finished goods. This involves managing critical functions such as batch record review and release, non-conformance and deviation investigations, corrective and preventive actions (CAPA), change control, and validation activities. They lead the site's quality team, which often includes managers and specialists in QA, QC, validation, and compliance, focusing on coaching, talent development, and fostering a pervasive culture of quality and continuous improvement across all departments. The typical career path to secure Site Quality Head jobs requires a strong educational foundation, usually a Bachelor’s or advanced degree in Life Sciences, Engineering, or a related technical field. Candidates must possess extensive experience, often 10-15 years, in quality roles within regulated manufacturing, with a significant portion in progressive leadership and people management. Essential skills include deep expertise in regulatory requirements, risk management, audit management, and root cause analysis. Success in this profession demands exceptional strategic thinking, communication, and influence skills to partner with Operations, Supply Chain, and R&D, driving quality as a shared business imperative. For those seeking to lead at the intersection of science, compliance, and operational leadership, Site Quality Head jobs offer a challenging and impactful career at the highest level of quality management.

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